Regulatory burden reduction

Health care providers are inundated with a growing number of regulatory requirements promulgated by various federal agencies. Although these policies are broadly intended to ensure that patients receive care that meets quality and safety standards, providers are confronted with the burden of regulatory compliance. Surgeons find themselves spending more time completing paperwork and other tasks to satisfy administrative requirements, taking away time with patients. The regulatory burdens on surgeons and their practices add hurdles to providing necessary care and increase spending on nonclinical activities.

In January 2017, the Trump Administration issued Executive Order 13771, which seeks to “manage the costs associated with the governmental imposition of private expenditures required to comply with Federal regulations.”* Following the release of this order, the U.S. Department of Health and Human Services (HHS) and the Centers for Medicare & Medicaid Services (CMS) began meeting with stakeholders to discuss physician burden and regulatory relief. To further define which regulations are most burdensome and should be modified, CMS launched the Patients over Paperwork initiative, under which agency officials will visit physician practices across the country to gather information on the administrative duties required of health care professionals.

The American College of Surgeons (ACS) has long supported policies that enhance patient care, reduce regulatory burden, and streamline clinical workflow. Over the past year, the ACS Division of Advocacy and Health Policy has positioned the College at the forefront of the regulatory relief movement. The ACS is an active participant in all regulatory reform events hosted by HHS and CMS, and provides feedback to federal leaders on the impact of unnecessary regulations on the provision of essential surgical services. In early 2018, the ACS launched its Stop Overregulating My OR [operating room] initiative, which describes specific actions that should be taken to reduce burdens and enable surgeons to reinvest their time and resources in patients. More information about the initiative is available on the ACS website.

This column provides an overview of the regulations that are most onerous for surgeons and describes ACS recommendations for reducing or eliminating these encumbrances.

What burdens are associated with the global codes data collection process, and what recommendations does the ACS have for easing these demands?

In July 2017, CMS began collecting data on postoperative visits furnished in the 10- and 90-day global period from physicians who are part of groups of 10 or more providers and who live in one of nine specified states. Under this mandatory reporting policy, which is intended to allow CMS to gather enough data on postoperative visits for the purpose of revaluing surgical services starting in 2019, physicians must report one Current Procedural Terminology (CPT) code 99024 for each postoperative evaluation and management (E/M) visit provided in the global period.†

This reporting requirement disproportionately affects physicians who provide global services. CMS failed to address numerous implementation issues or allow adequate time for provider education before the agency began collecting postoperative visit data. Furthermore, CMS has not assured providers that all claims submitted with the required data will be captured and counted, has not shared a comprehensive plan for data validation, nor has provided details on how the data will be used in the future.

The ACS urged CMS to delay the collection of global codes data until the agency corrects outstanding implementation issues, tests the reporting and data collection process, and shares a plan for data validation so that providers can confirm that submitted data are received and connected to the correct code. CMS began data collection without addressing these concerns.

The College asserts that CMS should not have imposed this burden on physicians until the data reporting process had been tested and proven to be effective. Without sufficient preparation, physician education, or a plan for data validation, the information collected is inherently flawed and of low statistical quality. Given these unresolved issues, the ACS recommends that CMS avoid using such data to revalue global services in 2019.

What burdens are associated with MIPS benchmarking, and what recommendations does the ACS have for easing these demands?

The Medicare Access and CHIP (Children’s Health Insurance Program) Reauthorization Act (MACRA) of 2015 requires that, starting in 2019, the Merit-based Incentive Payment System (MIPS) performance threshold be set at the mean or median of the composite performance scores for all MIPS-eligible physicians, thereby penalizing approximately half of Part B providers. It is purely speculative to consider how CMS will implement the rewards or penalties once the threshold is set. One option would include a graduated scale for rewards or penalties. A graduated scale would mean that physicians clustered near the mean/median would see less impact than physicians who are further from the mean/median. In such a scenario, those furthest from the mean/median would stand to gain or lose the most. Those details will remain unclear until CMS finalizes its benchmarking policy.

The MIPS benchmarking system is inadequate for measuring physician performance and lacks rigor in common data aggregation, common data analytics, and reporting. To accurately compare physicians’ MIPS data, CMS must use reliable methods, including standardized data definitions, risk adjustment/data analytics, data ascertainment methods, and data normalization methods. The ACS recommends that CMS provide additional flexibility in its benchmarking policy and allow more time to test and implement a statistically valid measure framework that follows care across an episode.

To address the flawed benchmarking process and lack of MIPS measures that are relevant to surgeons, the College is developing a comprehensive measure framework inclusive of high-value process measures across an episode of care, coupled with complementary patient-reported outcome and patient-reported experience measures. This framework provides an opportunity to accurately measure and compare surgeon performance across the phases of surgical care in alignment with a patient’s clinical flow.

What burdens are associated with prior authorization, and what recommendations does the ACS have for easing these demands?

Prior authorization (PA) is a process through which approval for coverage of a medical service or supply item must be obtained by a health care provider before the service or item may be furnished to a patient. PA requirements are overused and applied to all physicians, regardless of their ordering patterns or adherence to evidence-based clinical guidelines.

A 2017 ACS survey of nearly 300 Fellows and practice managers indicated that, on average, a surgical practice receives approximately 37 PA requests per surgeon per week, taking providers and staff 25 hours—the equivalent of three business days—to complete. Many practices must hire full-time employees who exclusively process PA requests, as the task of fulfilling all PA requirements, which often include lengthy phone calls and submission of voluminous medical records, is too tedious for physicians and other staff to perform while simultaneously interacting with patients. In addition, there is little to no consistency across insurers’ PA programs, forcing physicians and staff to spend significant time reviewing each insurer’s PA criteria and processes.

The administrative burdens associated with PA requirements often result in delayed or interrupted treatment and can lead to severe, life-threatening health outcomes. Many patients remain in the hospital while awaiting PA for necessary services or supplies that would allow them to be discharged earlier, which puts them at risk for complications.

The ACS asserts that PA requirements should be standardized across all insurers and that such requirements should be applied only to complex cases or to providers with ordering patterns that differ substantially from their colleagues’ after adjusting for patient population. PA should not be required for services or supplies that are standard for a specific condition or that previously have been approved as part of a patient’s care treatment plan. A reduction in the variation and scope of PA requirements across insurers could drastically reduce administrative costs to surgeons and ensure prompt delivery of care.

To better integrate PA processes into the clinical workflow, the ACS also recommends that PA requests, decisions, and appeals processes be automated through uniform electronic transaction portals for medical and pharmacy services. To ensure that patients have timely access to care, PA decisions should be transmitted by an insurer to a provider through the appropriate electronic portal within 24 hours for urgent care and 48 hours for non-urgent care. It is crucial that PA information be entered into electronic platforms shared by physicians, administrative staff, and insurers to streamline payor-provider communication and reduce the time and resources practices devote to PA.

What burdens are associated with E/M documentation guidelines, and what recommendations does the ACS have for easing these demands?

The E/M documentation guidelines were developed in 1995 when medical records were on paper. Back then, these guidelines created accountability to describe the level of E/M codes selected for the services billed. In the digital electronic health record (EHR) era, these guidelines are easily proliferated, creating voluminous medical records. The result is extraneous notes of little or no value, including the perpetuation of errors and misinformation. The EHR has become a hindrance to care and communication among providers.

Although it is important that physicians document their work, the current system requires unnecessary information, sometimes obscuring relevant and necessary data for patient care. The ACS recommends that CMS review and modernize E/M guidelines to reduce burdens, remove redundancies, and align use with EHRs. The College urges CMS to convene a group of physicians, including surgeon representatives, to explore the role of medical complexity, risk of medical decision making, and other factors that incorporate aspects of a patient’s overall health status into a new weighting of the E/M documentation requirements.

What burdens are associated with the skilled nursing facility three-day stay requirement, and what recommendations does the ACS have for easing these demands?

The skilled nursing facility (SNF) benefit is for Medicare patients who require a short-term intensive stay in a SNF. Beneficiaries must have a prior inpatient hospital stay of at least three consecutive days to be eligible for Medicare Part A coverage of SNF care. If a beneficiary is not admitted to a hospital as an inpatient for at least three days, Medicare will deny Part A payment for stays at a SNF. This requirement compromises some patients’ access to necessary post-hospital care coverage under Medicare and contributes to avoidable hospital admissions.

The three-day stay requirement assigns an arbitrary time frame to patient care and detracts from physicians’ clinical judgment in determining a patient’s status. The ACS recommends that CMS review this policy to determine if waiving the three-day stay requirement would reduce Medicare costs and maintain the quality of care provided to beneficiaries. The College supports a system where patients are assured that their care and financial obligations will not be adversely affected by their patient status and length of stay.

What burdens are associated with the Two-Midnight Rule, and what recommendations does the ACS have for easing these demands?

Under the Two-Midnight Rule, inpatient stays of less than two midnights after hospital admission are not considered medically necessary. The implementation of this policy, which was intended to reduce the number of short hospital inpatient stays and long outpatient stays, has resulted in negative consequences for physicians and Medicare beneficiaries. The Two-Midnight Rule has not resulted in a significant reduction in the number of long outpatient stays billed to Medicare, leading to higher costs and greater limitations for beneficiaries seeking SNF care following an outpatient stay under observation status.‡

The Two-Midnight Rule has failed to create uniform criteria for inpatient status or substantially reduce the number of long outpatient stays for Medicare beneficiaries. The ACS recommends that CMS rescind the Two-Midnight Rule in favor of physicians’ clinical judgment and the medical necessity of a hospital stay.

What burdens are associated with Medicare documentation, certification, and recertification requirements, and what recommendations does the ACS have for easing these burdens?

Medicare documentation policies set forth redundant requirements for verifying physician orders, delaying patient access to services and equipment. CMS only will pay for covered services if physicians certify and recertify medically necessary care and resources, including hospital stays, wheelchairs, colostomy supplies, diabetic testing supplies, physical therapy, and home health and hospice services. These documentation requirements are redundant and require physicians to review lengthy patient charts to confirm orders that they have already certified as medically necessary.

The ACS recommends that CMS take a more targeted approach to the enforcement of documentation and certification requirements. The College urges CMS to standardize and streamline this process and eliminate requirements for providers to regularly recertify a patient’s condition when the patient is diagnosed with a chronic illness. Authorization for certain types of medical supplies should also be standardized across suppliers so that providers are not required to recertify a patient’s need for such supplies each time a patient switches supply brands. The ACS also recommends that physicians be allowed to authorize their clinical staff, such as nurse practitioners and physician assistants, to complete certification forms on their behalf.

What burdens are associated with Medicare program integrity, and what recommendations does the ACS have for easing these demands?

Physicians are facing an increasing amount of prepayment and postpayment audits from CMS and its contractors. These audits often are voluminous and not completed in a timely manner, depriving physicians of reimbursement for extended periods. The number of reviews and types of contractors are confusing, add unwarranted physician burden and unnecessary costs, and disrupt and distract from delivering care.

Medicare and Medicaid audits are a great source of frustration and expense for surgeons. Physicians need a single, transparent, consistent, and fair review process to reduce administrative burdens. The ACS recommends that CMS develop a standardized approach for audit contractors to notify providers of a review, request medical records, inform providers of the specific reason a claim is denied, and clearly state a provider’s appeal rights.

Expenditures, such as printing and shipping fees for providers who receive clinical documentation requests from auditors, are high. The College urges CMS to require auditors to reimburse providers for the medical records submitted. Physicians who win an appeal of an audit should be reimbursed the full cost of complying with the review process by the auditing entity.

What burdens are associated with medical translator services, and what recommendations does the ACS have for easing these demands?

The HHS Office of Civil Rights requires all physicians who receive payments from any federal health program to provide access to verbal or written translation services for individuals with disabilities or limited English proficiency. HHS does not pay for medical translators and places the responsibility on physicians to offer translation services at no cost to patients. Hiring translators who are fluent in the appropriate dialect and are familiar with medical terminology is expensive, particularly when interpreters impose a time minimum for their services or charge travel and cancellation fees. Qualified medical translators can cost physicians hundreds of dollars per patient visit, and the cost of retaining a qualified translator often exceeds the total payment for the treatment provided.

The ACS believes that federal funding should be provided to physicians for the purposes of hiring medical translators to ensure continued access to care for patients with disabilities or limited English proficiency. The College recommends that the cost of medical translator services be considered part of the cost of care delivery and asks that CMS provide reimbursement for CPT code T1013, sign language or oral interpretive services, per 15 minutes.

To further reduce these costs to physicians, the ACS urges the HHS Office of Civil Rights to revise the definition of a “qualified interpreter” to allow the use of an adult, such as a relative or friend, accompanying a patient to interpret or facilitate communication.

What burdens are associated with the exchange of digital health information, and what recommendations does the ACS have for easing these demands?

The clinical care model is growing increasingly intricate, with a vast amount of information that must interoperate across different electronic platforms, thereby creating a high demand for the exchange of digital health information in a convenient and usable format. While patients receive care longitudinally over time, and not always in one facility or under one EHR, existing digital information exchange processes do not effectively track patients over time and space.

Without access to interoperable and usable digital health information, providers spend hours documenting and searching for information, which is extremely burdensome and detracts from patient care. The current digital environment cannot deliver the information physicians need to develop even a basic treatment plan, and surgeons are frustrated with an inefficient clinical workflow that reduces time with patients.

To enable digital health information interoperability across EHRs, mobile devices, registries, and patient clouds, the ACS recommends that HHS establish an interoperability framework and collaborate with the physician community, along with other stakeholders, to determine best practices for leveraging digital health information to improve health, enhance care, and optimize costs.

In addition, the College has partnered with Health Level Seven and the Health Services Platform Consortium to create national standards for the exchange, integration, and retrieval of digital health information. Once these standards are complete, the ACS recommends that CMS adopt them as a mandatory component of EHR certification to promote interoperability across health care providers, facilities, and insurers.